NCT06134908 PRevention of OsTEoporotiC FracTure 2 Pilot Study
| NCT ID | NCT06134908 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University |
| Condition | Fragility Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-13 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-01-13 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
With the aging of the world population, osteoporosis and fragility fractures have become global public health concerns. It has been estimated the population of people ≥60 years of age will increase from 229 million (16.2%) in 2017 to 479 million (35.1%) by 2050 in China. Because age is an important predictor of osteoporosis and fragility fracture, the incidence of fragility fracture has increased dramatically in China over the past decades. Timely treatment of osteoporosis is an effective way to decrease additional fracture risk among patients with fragility fractures, but anti-osteoporosis treatment rate is relatively low in China. Effective fracture prevention intervention is urgently needed in China. As a potential way to achieve effective risk communication, shared decision-making allows patients to be active participants in the management of osteoporosis. The investigators designed a multifaceted intervention, which was named as "Precise Education + Shared Decision-Making" program for the secondary prevention of fragility fractures based on behavioral theories, and assessed the effectiveness for fracture prevention using a pilot cluster randomized controlled trial among several hospitals in China. The aim of this pilot study is to test the acceptability and feasibility as well as preliminary efficacy of this program in patients with fragility fractures.
Eligibility Criteria
Inclusion Criteria: 1. Local residents (live in the city where the hospital is located for half a year or more); 2. Hospitalized patients with fractures aged 50 years and above; 3. First fracture, without history of fracture; 4. Never diagnosed as "osteoporosis" before admission; 5. No fracture history, and never receive any bone mineral density test, and never take anti-osteoporosis medication in the 4 years before admission; 6. Hospitalized patients with the following fractures: hip fracture, thoracic spine fracture, and lumbar spine fracture; 7. New fragility fracture: fracture that occurs after minor trauma or daily activities, such as a fracture caused by a fall from standing height or less; fracture happened within 6 weeks; 8. Not living in a nursing or rehabilitation institution before fracture; 9. Possess reading ability, and can read and understand informed consent forms or medical materials independently. Exclusion Criteria: 1. Patients with pathological fractures caused by tumor or infection; 2. Patients with cognitive dysfunction or mental disorder; 3. AIDS patients; 4. Patients who refuse to follow-up, or have poor compliance for follow-up, or fail to understand and cooperate for follow-up; 5. Hearing or visual impairment, and unable to communicate or read materials; 6. Patients who have participate in other studies; 7. Other conditions that the investigator considered inappropriate to enroll.
Contact & Investigator
Jian Mo, MD
PRINCIPAL INVESTIGATOR
Third Affiliated Hospital, Sun Yat-Sen University
Frequently Asked Questions
Who can join the NCT06134908 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Fragility Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06134908 currently recruiting?
Yes, NCT06134908 is actively recruiting participants. Contact the research team at mojian3@mail.sysu.edu.cn for enrollment information.
Where is the NCT06134908 trial being conducted?
This trial is being conducted at Changsha, China, Dongguan, China, Guangzhou, China, Hangzhou, China and 3 additional locations.
Who is sponsoring the NCT06134908 clinical trial?
NCT06134908 is sponsored by Third Affiliated Hospital, Sun Yat-Sen University. The principal investigator is Jian Mo, MD at Third Affiliated Hospital, Sun Yat-Sen University. The trial plans to enroll 50 participants.